CN1351867A - Levo-potasisum magnesium asparate infusion injection and preparing method - Google Patents
Levo-potasisum magnesium asparate infusion injection and preparing method Download PDFInfo
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- CN1351867A CN1351867A CN 01133484 CN01133484A CN1351867A CN 1351867 A CN1351867 A CN 1351867A CN 01133484 CN01133484 CN 01133484 CN 01133484 A CN01133484 A CN 01133484A CN 1351867 A CN1351867 A CN 1351867A
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Abstract
A leveo-potassium magnesium aspartate infusion injection consists of levo-potassium aspartate, levo-magnesium asparatate, osmotic pressure regulator and pH regulator. It is a kind of electrolyte extender for infusion, and has pH value of 5-11.5, high concentration, large dosage, high stability and no pollution. it has wide application range, and is suitable for intravenously guttae to treat arrhythmia caused by various causes, chronic alcoholism fremitus, myocardiopathy as diabetes complication, etc. and applicaltion in heart operation. It is also suitable for acute and chronic hepatitis, intrahepatic cholestasis, and disease of respiratory system, nerve system and metabolic system.
Description
Technical field:
The invention belongs to electrolyte complementary medical, particularly a kind of levo-potasisum magnesium asparate infusion injection also relates to the preparation method of this injection simultaneously.
Background technology:
Levo-potassium magnesium aspartate is the more stronger medicine of Physiology and biochemistry effect, be applicable to the auxiliary treatment of the diseases such as arrhythmia that a variety of causes causes, in recent years this product purposes is clinically widened to some extent, as be applied to that chronic alcoholism is trembled, diabetes merge cardiomyopathy etc. treatment and the application in operation on heart.The dosage form of clinical practice at present is an aqueous injection, causes secondary pollution when clinical use easily, and liquor strength is low excessively simultaneously, use extremely inconvenience clinically, and range of application is narrower.
Summary of the invention:
The object of the present invention is to provide a kind of high concentration, heavy dose, physical and chemical stability is good, and is pollution-free, applied range, and be convenient to operation, be suitable for the levo-potasisum magnesium asparate infusion injection of large-scale production.
Another object of the present invention is to provide the preparation method of this injection.
The object of the present invention is achieved like this: the present invention forms and to comprise left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate, osmotic pressure regulator and pH regulator agent, and parts by weight are:
Left-handed-aspartic acid 0.5-10 part
Left-handed-Magnesium Aminosuccinate 0.5-10 part
The pH regulator agent is an amount of
Osmotic pressure regulator 2.25-100 part
The present invention is the transfusion injection; pH value is between 5-11.5; optimum pH between 6.2-7.8, its purposes widen for: be applicable to various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system (to protecting neuron from acute), nervous system and metabolic disease, with the intravenous drip administration.Wherein left-handed-aspartic acid can be selected its anhydride or crystalline hydrate, also can be to be obtained when the preparation injection by left-handed-Aspartic Acid and potassium hydroxide or potassium carbonate; Left-handed-Magnesium Aminosuccinate can be selected its anhydride or crystalline hydrate, also can be to be obtained when preparing injection by left-handed-Aspartic Acid and magnesium hydroxide, magnesium oxide, magnesium carbonate; The levo-potassium magnesium aspartate osmotic pressure regulator is the water solublity proppant, is selected from mannitol, glucose, NaCl, dextran; The pH value regulator is a water solublity, make the levo-potasisum magnesium asparate infusion injection pH value in the scope that body can bear, be selected from diethanolamine, monoethanolamine, diisopropylamine, diisopropanolamine (DIPA), triethanolamine, 1,2-hexamethylene diamine, natrium carbonicum calcinatum, sal soda, monohydrated sodium carbonate, isopropanolamine, monoethanolamine, sodium hydroxide, sodium citrate, sodium hexametaphosphate, Polymeric sodium metaphosphate., sodium bicarbonate, sodium hydrogen phosphate.
The preparation method of levo-potasisum magnesium asparate infusion injection provided by the invention is: get recipe quantity left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate add water and stir, and to proper range, makes its dissolving with pH regulator agent adjust pH; Other gets isoosmotic adjusting agent and adds the water for injection stirring and dissolving; Above-mentioned two liquid are mixed, add the pin activated carbon of 0.1-0.3% (W/V), filter de-carbon, degerming, fill are sterilized, promptly in 250ml hard infusion bottle.
The present invention compared with prior art, the present invention is the transfusion injection, pH value is between 5-11.5, have the following advantages: the concentration height, dosage is big, good stability, pollution-free, be convenient to operation, be suitable for large-scale production, applied range is except that being applicable to that arrhythmia that a variety of causes causes, the chronic smart toxic tremor, diabetes of spilling merge the treatment and the application in operation on heart of cardiomyopathy etc., also be applicable to the frontier of various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system, nervous system and metabolic disease, with the intravenous drip administration.
The specific embodiment:
Be described in further detail the present invention below by embodiment.
Embodiment 1:
(1) preparation prescription:
Left-handed-Aspartic Acid 3400g
Potassium hydroxide 65.4g
Magnesium oxide 27.8g
Mannitol 50000.0g
Sodium hydroxide is an amount of
Water for injection 250000ml
Prepare 1000 bottles
(2) preparation technology: get recipe quantity left-handed-Aspartic Acid, potassium hydroxide, magnesium oxide add injection water 15000ml, stirs, and add 40% sodium hydroxide solution and transfer pH5-11.5, makes whole dissolvings; Mannitol adds injection water 20000ml, stirs and makes its dissolving; Two liquid mixing are added 0.1% pin activated carbon, and stirring at room 20min filters de-carbon, after the microporous filter membrane degerming, adds sterile water for injection to 250000ml, and behind the mensuration content, fill is in 250ml hard glass infusion bottle, and sterilization gets product.
Embodiment 2
(1) preparation prescription:
Left-handed-aspartic acid 3000g
Left-handed-Magnesium Aminosuccinate 3000g
Glucose 25000.0g
Sodium hydrogen phosphate is an amount of
Water for injection 250000ml
Prepare 1000 bottles
(2) preparation technology: with embodiment 1.
Embodiment 3
(1) preparation prescription:
Left-handed-Aspartic Acid 8500g
Potassium carbonate 288.8g
Magnesium oxide 69.6g
Dextran-40 15000.0g
Isopropanolamine is an amount of
Water for injection 250000ml
Prepare 1000
(2) preparation technology: with embodiment 1.
Embodiment 4
(1) preparation prescription:
Left-handed-Aspartic Acid 1700g
Potassium hydroxide 32.7g
Magnesium oxide 13.9g
Dextran-20 15000.0g
Sodium carbonate is an amount of
Water for injection 250000ml
Prepare 1000 (2) preparation technologies: with embodiment 1.
Embodiment 5 (1) preparation prescriptions:
Left-handed-aspartic acid 1/2H
2O 2500g
Left-handed-Magnesium Aminosuccinate 4H
2O 2500g
Sodium chloride 2250.0g
Ammonium carbonate is an amount of
Water for injection 250000ml
Prepare 1000 (2) preparation technologies: with embodiment 1.
Claims (10)
1, a kind of levo-potasisum magnesium asparate infusion injection is characterized in that: its composition comprises left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate, osmotic pressure regulator and pH regulator agent, and parts by weight are:
Left-handed-aspartic acid 0.5-10 part
Left-handed-Magnesium Aminosuccinate 0.5-10 part
The pH regulator agent is an amount of
Osmotic pressure regulator 2.25-100 part
2, levo-potasisum magnesium asparate infusion injection according to claim 1 is characterized in that: this injection is the transfusion injection.
3, levo-potasisum magnesium asparate infusion injection according to claim 1 is characterized in that: this injection also is applicable to various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system, nervous system and metabolic disease, with the intravenous drip administration.
4, the preparation method of levo-potasisum magnesium asparate infusion injection according to claim 2, it is characterized in that: get recipe quantity left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate add injection and blunge, to proper range, make its dissolving with pH regulator agent adjust pH; Other gets osmotic pressure regulator and adds the water for injection stirring and dissolving; Above-mentioned two liquid are mixed, add the pin activated carbon of 0.1-0.3% (W/V), filter de-carbon, degerming, fill are sterilized, promptly in 250ml hard infusion bottle.
5, according to claim 1 or 4 described levo-potasisum magnesium asparate infusion injection and preparation methoies, it is characterized in that: its pH value is between 5-11.5.
6, according to claim 1 or 3 described levo-potasisum magnesium asparate infusion injection and preparation methoies, it is characterized in that: described left-handed-aspartic acid is anhydride or crystalline hydrate and obtained when preparing injection by left-handed-Aspartic Acid and potassium hydroxide or potassium carbonate.
7, according to claim 1 or 4 described levo-potasisum magnesium asparate infusion injection and preparation methoies, it is characterized in that: described left-handed-Magnesium Aminosuccinate is anhydride or crystalline hydrate and obtained when the preparation injection by left-handed-Aspartic Acid and magnesium hydroxide, magnesium oxide, magnesium carbonate.
8, according to claim 1 or 4 described levo-potasisum magnesium asparate infusion injection and preparation methoies, it is characterized in that: described osmotic pressure regulator is a water solublity, is selected from mannitol, glucose, NaCl, dextran.
9, according to claim 1 or 4 described levo-potasisum magnesium asparate infusion injection and preparation methoies, it is characterized in that: described pH value regulator is a water solublity, be selected from diethanolamine, monoethanolamine, diisopropylamine, diisopropanolamine (DIPA), triethanolamine, 1, the 2-hexamethylene diamine, natrium carbonicum calcinatum, sal soda, monohydrated sodium carbonate, isopropanolamine, sodium hydroxide, potassium hydroxide, sodium citrate, potassium citrate, the D-sodium potassium tartrate tetrahydrate, potassium metaphosphate, Kurrol's salt, Polymeric sodium metaphosphate., sodium bicarbonate, potassium bicarbonate, ammonium carbonate, sodium hydrogen phosphate, dipotassium hydrogen phosphate.
10, levo-potasisum magnesium asparate infusion injection according to claim 5 and preparation method is characterized in that: its optimum pH is between 6.2-7.8.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01133484 CN1351867A (en) | 2001-11-22 | 2001-11-22 | Levo-potasisum magnesium asparate infusion injection and preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01133484 CN1351867A (en) | 2001-11-22 | 2001-11-22 | Levo-potasisum magnesium asparate infusion injection and preparing method |
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| Publication Number | Publication Date |
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| CN1351867A true CN1351867A (en) | 2002-06-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 01133484 Pending CN1351867A (en) | 2001-11-22 | 2001-11-22 | Levo-potasisum magnesium asparate infusion injection and preparing method |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1829540A1 (en) * | 2004-12-10 | 2007-09-05 | Ajinomoto Co., Inc. | Preventive/therapeutic composition for liver disease |
| CN100450476C (en) * | 2007-02-15 | 2009-01-14 | 北京京卫信康医药科技发展有限公司 | Electrolyte complementary medical combination for injection |
| CN103664668A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Preparation method of potassium aspartate crude drug |
| CN104352452A (en) * | 2014-10-09 | 2015-02-18 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder for injection and preparation method of potassium magnesium aspartate freeze-dried powder |
| CN105055388A (en) * | 2015-08-11 | 2015-11-18 | 瑞阳制药有限公司 | Potassium magnesium aspartate injection and preparation method thereof |
| CN108969493A (en) * | 2018-09-06 | 2018-12-11 | 海南通用康力制药有限公司 | A kind of potassium magnesium aspartate for injection is freeze-dried and its manufacturing method |
| CN109053478A (en) * | 2018-08-22 | 2018-12-21 | 上海青平药业有限公司 | A kind of preparation method of potassium L-aspartate magnesium salts |
-
2001
- 2001-11-22 CN CN 01133484 patent/CN1351867A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1829540A1 (en) * | 2004-12-10 | 2007-09-05 | Ajinomoto Co., Inc. | Preventive/therapeutic composition for liver disease |
| EP1829540A4 (en) * | 2004-12-10 | 2008-04-02 | Ajinomoto Kk | Preventive/therapeutic composition for liver disease |
| CN100450476C (en) * | 2007-02-15 | 2009-01-14 | 北京京卫信康医药科技发展有限公司 | Electrolyte complementary medical combination for injection |
| CN103664668A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Preparation method of potassium aspartate crude drug |
| CN104352452A (en) * | 2014-10-09 | 2015-02-18 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder for injection and preparation method of potassium magnesium aspartate freeze-dried powder |
| CN105055388A (en) * | 2015-08-11 | 2015-11-18 | 瑞阳制药有限公司 | Potassium magnesium aspartate injection and preparation method thereof |
| CN109053478A (en) * | 2018-08-22 | 2018-12-21 | 上海青平药业有限公司 | A kind of preparation method of potassium L-aspartate magnesium salts |
| CN108969493A (en) * | 2018-09-06 | 2018-12-11 | 海南通用康力制药有限公司 | A kind of potassium magnesium aspartate for injection is freeze-dried and its manufacturing method |
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